1. Field of the Invention
The present invention relates to unique programmed-release pharmaceutical dosage forms comprising ambroxol hydrochloride.
2. Description of the Prior Art
Ambroxol, 4-[[(2-amino-3,5-dibromophenyl)methyl]amino]cyclohexanol or N-(trans-p-hydroxycylohexyl)-(2-amino-3,5-dibromobenzyl)amine, is a known compound (compare, for example, U.S. Pat. No. 3,536,713). Ambroxol hydrochloride too is known to this art, as is the pharmaceutical activity thereof. Ambroxol.multidot.HCl, for example, is a safe and effective expectorant. Nonetheless, it possesses a relatively short biological half-life and, therefore, it typically must be administered at least three times a day in order to elicit its full activity.
Thus, need continues to exist in this art for an improved dosage form of ambroxol.multidot.HCl that will permit a decrease in the number of administrations, to not only reduce the burden on the patient but also to increase his compliance, thus providing greater therapeutic benefits.